NCT03799354 Study on Impact of Maximal Strength Training in Patients With COPD
| NCT ID | NCT03799354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-09-18 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2019-09-18 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events. Maximal Strength Training (MST) is a kind of RT typically performed at \~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations. When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency. Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
Eligibility Criteria
Inclusion Criteria: * COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) \< 70%, and FEV1 \< 50% of predicted * stable clinical condition Exclusion Criteria: * pulmonary diseases other than COPD * type II diabetes or other metabolic diseases * malign disease * a respiratory tract infection within the last 4 wks * long oxygen therapy use.
Contact & Investigator
Mara Paneroni, MSc, PT
PRINCIPAL INVESTIGATOR
Istituti Clinici Scientifici Maugeri
Frequently Asked Questions
Who can join the NCT03799354 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03799354 currently recruiting?
Yes, NCT03799354 is actively recruiting participants. Contact the research team at mara.paneroni@icsmaugeri.it for enrollment information.
Where is the NCT03799354 trial being conducted?
This trial is being conducted at Lumezzane, Italy.
Who is sponsoring the NCT03799354 clinical trial?
NCT03799354 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Mara Paneroni, MSc, PT at Istituti Clinici Scientifici Maugeri. The trial plans to enroll 20 participants.